Geli's new hepatitis C drug has won the priority review and is "close to the market"

On February 28, according to the information publicized by the drug review center of the State Food and drug administration, the listing application of danorevir sodium, a new hepatitis C drug of Geli Pharmaceutical (Zhejiang) Co., Ltd., was included in the priority review channel This means that danorevir is expected to become the first small molecule antiviral drug in China Danorevir: the first innovative hepatitis C drug in Geli, danorevir (asc08), is a direct antiviral drug (DAA) with independent intellectual property rights It belongs to NS3 / 4A protease inhibitor of the second generation of hepatitis C virus (HCV) Danorevir is a hepatitis C drug introduced by golly from Roche with independent intellectual property rights, aiming to fill the gap of domestic DAA drugs Since the first clinical application in early 2014, danorevir has been developing faster than other similar drugs At the beginning of 2016, danorevir obtained the special support of "major new drug creation" science and technology of the 13th five year plan At the end of December of the same year, Geli announced that danorewei's listing application had passed the comprehensive on-site inspection of Zhejiang food and Drug Administration and was accepted by the State Food and Drug Administration (CFDA) In February 2017, at the 26th annual meeting of the Asia Pacific Society of Hepatology (apsal), golly reported the latest research data of innovative drugs for hepatitis C under golly Clinical data revealed that danorevir combined with PR triple regimen (asc08 + pegylated interferon α - 2A + ribavirin) can cure 96% of Chinese patients with type I non cirrhotic hepatitis C for 12 weeks In addition to danorevir, there is another innovative hepatitis C drug in Geli's research product line: rivadavir (asc16, NS5A inhibitor), which, in combination with danorevir, forms the first native native all oral interferon free treatment scheme in China In April 2016, revadavir was included in the priority review procedure by the State Food and drug administration According to the latest clinical data, the cure rate of danorevir combined with ravidavir is 100% in 12 or 24 weeks This curative effect is similar to that of similar drugs in the world, and it is expected to benefit the vast number of hepatitis C patients in China Geli in research product line (from the company's official website) 2 Chinese hepatitis C patients: look forward to DAA drug hepatitis C is a viral hepatitis caused by hepatitis C virus (HCV) infection Chronic hepatitis C is an important inducement of liver cirrhosis and liver cancer At present, the total number of people infected with HCV in China is 10-30 million, and it is expected that the number of new diseases will increase rapidly year by year in the future In 2013, the second generation of DAA drugs, represented by sovaldi, was approved by FDA, marking a breakthrough in the fight against hepatitis C However, in the fierce momentum that pharmaceutical giants such as Gilead, Johnson & Johnson, and Bristol Myers have successively developed and launched the full oral treatment drug portfolio, China's domestic market has not yet listed DAAS According to the guideline for the prevention and treatment of hepatitis C (2015 Edition), pegylated interferon combined with ribavirin (PR) was still the main treatment plan for hepatitis C patients in China at present However, there are some problems in this treatment, such as low cure rate, poor tolerance and long treatment cycle Many patients try to buy generic drugs produced by pharmaceutical companies in India and other countries through informal channels for treatment, but they are faced with many uncertainties and risks Therefore, whether it is triad or all oral combination program, it is the drug that domestic hepatitis C patients are looking forward to A number of domestic enterprises, including Geli, ginkgo tree, dongyangguang, etc., are trying to speed up the clinical and marketing of direct antiviral drugs, and strive to make patients use of affordable and efficient treatment drugs as soon as possible